FDA greenlights first newborn screening test aid for Duchenne muscular dystrophy

Labs now have the option to add the PerkinElmer kit to newborn screening panels, coinciding with a controversial FDA turnaround in approving a new treatment for the rare genetic disorder.

By Maria Rachal • Dec. 12, 2019

EC medical device group sheds new light on MDR, IVDR sampling codes

The Medical Device Coordination Group also issued a guidance explaining codes used to define the scope of a notified body's designation.

By Nick Paul Taylor • Dec. 12, 2019

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

BioMarin taps Invitae to expand genetic testing for skeletal dysplasia

As it develops drug treatment for a form of skeletal dysplasia, BioMarin is bankrolling a program in which medical genetic testing company Invitae will screen for 109 genes linked to rare bone and joint disorders.

By Nick Paul Taylor • Dec. 11, 2019

Roche MRSA test wins FDA De Novo OK

The agency said the novel diagnostic technology can deliver results in as few as five hours, versus the one to two day wait with conventional methods. 

By Nick Paul Taylor • Dec. 6, 2019

Philips to offer Paige.AI's prostate cancer detection tech

Weeks after Memorial Sloan Kettering Cancer Center spinout Paige.AI won a CE mark for its diagnostic tools, Philips announced it will combine its own digital pathology capabilities with the startup's prostate cancer product.

By Dana Elfin • Dec. 5, 2019

FDA grants breakthrough status to eye-tracking Parkinson's test

The diagnostic test is designed to detect persistent ocular tremors, a symptom research suggests appears early and is pervasive in Parkinson's patients.

By Nick Paul Taylor • Dec. 4, 2019

MRI screening linked to improved detection of breast cancer

The New England Journal of Medicine study found fewer cases of cancer are missed when MRIs are performed. At the same time, the scans come with a high rate of false positives, calling the utility of additional imaging into question.

By Nick Paul Taylor • Dec. 2, 2019

Feds charge lab owner in latest genetic testing kickback scheme

The charges come just two months after the Department of Justice shone the light on an alleged scam involving 35 people and multiple genetic testing and telemedicine companies costing Medicare $2.1 billion.

By Susan Kelly • Dec. 2, 2019

FDA approves TB test from Qiagen and DiaSorin

The approval could be a win-win for both companies, bringing Qiagen's TB blood test to DiaSorin's ​Liaison immunoassay analyzers while expanding the testing menu for Liaison. 

By Nick Paul Taylor • Dec. 2, 2019

Boston Heart to pay $26.7M to settle alleged doctor kickback scheme

Allegations against the clinical diagnostics company included that it made payments to doctors disguised as investment returns in exchange for referrals.

By Susan Kelly • Nov. 27, 2019

Roche facing $137M in damages over diagnostic patent dispute after jury verdict

The ruling relates to technology used in Roche's cobas line of immunoassay analyzers.

By Nick Paul Taylor • Nov. 27, 2019

Carolina Liquid gets FDA warning over sale of unauthorized reagents

FDA said Carolina Liquid distributed Class I and II IVD reagents without regulatory clearance. The warning is the latest in a series of letters issued this year to companies for distributing devices without premarket approval. 

By Nick Paul Taylor • Nov. 20, 2019

Qiagen in talks with potential buyers amid weak results, restructuring

The molecular test maker confirmed Friday it has received several non-binding indications of interest, days after Bloomberg reported Thermo Fisher was eyeing a takeout of Qiagen.

By Susan Kelly • Nov. 18, 2019

BARDA backs Inflammatix test to improve antibiotic use

The $6 million contract will fund efforts to distinguish between bacterial and viral infections in a bid to limit overprescribing of antibiotics and the emergence of superbugs.

By Nick Paul Taylor • Nov. 15, 2019

Paige gets CE mark for prostate cancer detection technology

The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.

By Nick Paul Taylor • Nov. 13, 2019

FDA grants breakthrough status to AI-based gastric cancer diagnostic

The technology uses artificial intelligence to analyze endoscopy images for signs of gastric cancer.

By Nick Paul Taylor • Nov. 12, 2019

Exact Sciences closes Genomic Health deal, wins breakthrough tag for liver cancer blood test

The Cologuard maker said it intends to roll out the test for hepatocellular carcinoma in the second half of 2020.

By Maria Rachal • Nov. 8, 2019

Triple-digit liquid biopsy growth powers Guardant to beat-and-raise quarter

Guardant Health raised its full-year revenue guidance by around 10% after blasting past expectations.

By Nick Paul Taylor • Nov. 8, 2019

Hologic beats sales outlook on diagnostics, breast health

The women's health-focused company said it's planning to fuel further growth with more tuck-in acquisitions. But analysts gave a muted response to the results and shares were down 5% Thursday morning. 

By Nick Paul Taylor • Nov. 7, 2019

FDA authorizes 1st NGS test for HIV drug resistance mutation

By detecting 342 HIV drug resistance mutations in blood samples, the next-generation sequencing test gives physicians a different way to assess resistance and tailor treatments to patients, the agency said.

By Nick Paul Taylor • Nov. 6, 2019

Myriad shares plunge 40% after missing targets, slashing outlook

Investors punished the genetic test maker after it reported double-digit drops in sales of its key cancer and depression products.

By Nick Paul Taylor • Nov. 5, 2019

Sharp drop in Chinese sales drags Qiagen down in Q3

Sales in China fell 24% in the quarter, which Qiagen attributed to a slowdown in distributor orders and the end of its next generation sequencing joint venture.

By Nick Paul Taylor • Oct. 31, 2019

Exact Sciences Q3 revenue jumps 85% but Cologuard orders disappoint

Shares in the non-invasive colon cancer test manufacturer fell approximately 6% Wednesday. Exact plans to focus on increasing payer coverage of Cologuard and communicating its label expansion to doctors.

By David Lim • Oct. 30, 2019

CMS proposes lifting restrictions on NGS cancer testing

The agency revised its proposed national coverage determination after receiving more than 80 comments, with potential plans to extend coverage of next generation sequencing tests to earlier-stage and hereditary cancers.

By Nick Paul Taylor • Oct. 30, 2019

UK regulator mulls blocking Illumina's $1.2B PacBio takeover

The watchdog said the union "would result in a significant reduction of competition," leading some analysts to predict the deal won't go through.

By Nick Paul Taylor • Oct. 25, 2019